Cetuximab Rechallenge in Irinotecan-pretreated mCRC, KRAS, NRAS and BRAF Wild-type Treated in 1st Line With Anti-EGFR Therapy (CRICKET).

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT02296203
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a multicentric, phase II single-arm study in which KRAS, NRAS and BRAF wild-type, irinotecan-resistant metastatic colorectal cancer patients progressing after an initial response to a first-line cetuximab-containing therapy, receive a rechallenge third-line treatment with cetuximab plus irinotecan.

Key Dates

Start date
Oct 31, 2014
Status verified
Feb 2018
Primary completion
Jun 19, 2017
Completion
Jun 15, 2018

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cetuximab and irinotecan

Primary Outcome Measure

percentage of patients achieving a decrease equal or more than 30% in the sum of the longest diameters of target lesions [ Time Frame: evaluation every 8 weeks until 48 weeks ]

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